Disease-modifying therapies (DMTs) discontinuation in older relapsing-remitting multiple sclerosis (RRMS) patients...

Disease-modifying therapies (DMTs) are the mainstay of relapsing-remitting multiple sclerosis (RRMS) treatment. Their efficacy decreases with age, while risks such as infections increase. This study aimed to evaluate the safety and clinical outcomes of DMT discontinuation in patients with RRMS aged 55 years and older.

We conducted a randomized clinical trial including 178 patients with RRMS aged ≥55 years, EDSS ≤3, and no relapses or MRI activity for at least 5 years. Patients were randomized to continue DMTs (n=89) or discontinue (n=89). Clinical relapses, EDSS scores, and MRI activity were assessed over 24 months.

Relapses occurred in 9 (10.7%) patients in the continuation group and 12 patients (14.3%) in the discontinuation group (Risk Ratio [RR] = 1.33, 95% CI: 0.60 to 2.98; P=0.48). MRI activity was detected in 6 patients (7.1%) continuing DMTs and 9 (10.7%) patients who discontinued (RR = 1.50, 95% CI: 0.56 to 4.02; P=0.41). EDSS scores increased slightly in both groups during the first year. At 24 months, the mean EDSS was 1.59 (±0.74) in the continuation group and 1.36 (±0.74) in the discontinuation group, with no statistically significant difference between groups (mean difference = 0.23, 95% CI: -0.002 to 0.46; P=0.05).

In patients aged ≥55 years with stable RRMS, discontinuation of DMTs did not significantly increase relapses, disability progression, or MRI activity compared with continuation. These findings suggest that DMT discontinuation may be a safe and reasonable option for selected older patients. Larger, multicenter studies with longer follow-ups are warranted.